Bioassay Scientist Jobs

Valentia Analytical is seeking a Bioassay Scientist to join our CGMP Quality Analytical Team in Fremont, CA to be primarily responsible for Bioassay, ELISA and other plate-based testing. This is a uniquely exciting opportunity for those without direct experience to gain such across a multitude of assays and sample types including proteins, small molecules, and gene therapeutic products. There is also great opportunity to gain mastery in other analytical techniques including UHPLC, CIEF, CESDS, GC-MS, and physico-chemical. This is a quality-focused company offering elite analytical support to clients of the biotechnological, pharmaceutical, and gene-therapeutic industries. The company is committed to strong systems. This commitment enabled the company to achieve ISO17025:2017 accreditation by the ANSI National Accreditation Board in its first year of operation and has maintained it since. We specifically seek individuals looking to be part of culture fostering quality, clean work, and a positive team supporting environment.

• Develop/transfer, validate, perform, and maintain analytical assays primarily for Bioassay and ELISA and Bioassay to characterize biomolecules for potency.
• Execute analytical methods validations in accordance with ICH Q2.
• Author technical documents including test methods, equipment procedures, development reports, validation protocols/reports, and/or investigation reports.
• Maintain compliance CGMP and laboratory systems such as those managing samples, reagents, equipment, and documentation.
• Enforce FDA regulatory requirements including 21CFR11, 21CFR210, 21CFR211

Summary Of Qualifications

• The candidate should be able to work and troubleshoot independently in a CGMP compliant environment.
• The candidate will be capable of learning new skills and multi-tasking independently.
• Bachelor’s or master’s degree in Chemistry, Biology, Biochemistry or other related field,
• Preferably 3-5 years laboratory experience performing ELISA and/or Bioassay within a GMP environment testing proteins and/or antibody-drug conjugates.